European Federation for Exploratory Medicines Development Lyon Conference 2019: The Changing Landscape of Early Medicines Development—Be Prepared by Tim Hardman, Henri Caplain, Sylvie Rottey, Desiree Douglas, Steffan Stringer, Hildegard Sourgens

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The Therapeutic Landscape of Salivary Gland Malignancies—Where Are We Now? by Robbert Cleymaet, Tijl Vermassen, Renaat Coopman, Hubert Vermeersch, Stijn De Keukeleire, Sylvie Rottey

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Immuno-Oncological Biomarkers for Squamous Cell Cancer of the Head and Neck: Current State of the Art and Future Perspectives by Stijn J. De Keukeleire, Tijl Vermassen, Elien Hilgert, David Creytens, Liesbeth Ferdinande, Sylvie Rottey

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Prognostic Features of Near-Infrared Spectroscopy Following Primary Radical Prostatectomy by Tijl Vermassen, Jonas Himpe, Renaat Coopman, Charles Van Praet, Nicolaas Lumen, Sylvie Rottey, Joris Delanghe

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Tumor-Infiltrating Lymphocytes in Head and Neck Cancer: Ready for Prime Time? by Alhadi Almangush, Stijn De Keukeleire, Sylvie Rottey, Liesbeth Ferdinande, Tijl Vermassen, Ilmo Leivo, Antti A. Mäkitie

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The New First-in-Human EMA Guideline: Disruptive or Constructive? Outcomes From the First EUFEMED Discussion Forum by Kerstin Breithaupt-Grögler, Tim Hardman, Tim Hardman, Jan de Hoon, Yves Donazzolo, Sylvie Rottey, Hildegard Sourgens, Steffan Stringer

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Infrared Spectroscopy: A New Frontier in Hematological Disease Diagnosis by Charlotte Delrue, Reinhart Speeckaert, Matthijs Oyaert, Tessa Kerre, Sylvie Rottey, Renaat Coopman, Wouter Huvenne, Sander De Bruyne, Marijn M. Speeckaert

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Concordance, Correlation, and Clinical Impact of Standardized PD-L1 and TIL Scoring in SCCHN by Stijn Jeroen De Keukeleire, Tijl Vermassen, Philippe Deron, Wouter Huvenne, Fréderic Duprez, David Creytens, Jo Van Dorpe, Liesbeth Ferdinande, Sylvie Rottey

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Phase 1 Study Evaluating the Association of the Cyclin-Dependent Kinase 4/6 Inhibitor Ribociclib and Cetuximab in Recurrent/Metastatic p16-Negative Squamous Cell Carcinoma of the H... by Emmanuel Seront, Emmanuel Seront, Sandra Schmitz, Matthias Papier, Aline van Maanen, Stéphanie Henry, Christophe Lonchay, Sylvie Rottey, Gabrielle van Caloen, Jean-Pascal Machiels

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An open‐label, nonrandomized, phase Ib feasibility study of cusatuzumab in patients with nasopharyngeal carcinoma by Astrid De Meulenaere, Tijl Vermassen, David Creytens, Stijn De Keukeleire, Tim Delahaye, Philippe Deron, Fréderic Duprez, Samson Fung, Patrick Pauwels, Liesbeth Ferdinande, Sylvie Rottey

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Assessment of pharmacokinetics, safety, and tolerability following twice‐daily administration of molnupiravir for 10 days in healthy participants by Marian Iwamoto, Kelly E. Duncan, Prachi K. Wickremasingha, Tian Zhao, Maria V. Liberti, Lieselotte Lemoine, Tatjana Decaesteker, Sylvie Rottey, Brian M. Maas, Gillian Gillespie, S. Aubrey Stoch

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728 A phase 1/2 study of JK08, an IL-15 antibody fusion protein targeting CTLA-4, in patients with advanced solid tumors by Sylvie Rottey, Valentina Boni, Naimish Pandya, Elena Garralda, Shalabh Singhal, Vladimir Galvao, Nuria Kotecki, Maria de Miguel, Brant Delafontaine, Omar Saavedra, Amanda McEwen, Samuel L Murphy

Combined high dose radiation and pazopanib in metastatic renal cell carcinoma: a phase I dose escalation trial by Katrien De Wolf, Sylvie Rottey, Karim Vermaelen, Karel Decaestecker, Nora Sundahl, Lizzy De Lobel, Els Goetghebeur, Gert De Meerleer, Nicolaas Lumen, Valérie Fonteyne, Daan De Maeseneer, Piet Ost

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340 Phase 1 study of AMG 160, a half-life extended BiTE® (bispecific T-cell engager) therapy targeting prostate-specific membrane antigen, in patients with metastatic castration-re... by Ben Tran, Nabil Adra, Jean-Pascal Machiels, Sylvie Rottey, Tanya Dorff, Lisa Horvath, Matthew Rettig, Martijn Lolkema, Karen Autio, Richard Greil, Shirley Poon, Daniel Tan, Gabor Jurida, Hosein Kouros-Mehr

The Role of Cytoreductive Radical Prostatectomy in the Treatment of Newly Diagnosed Low-volume Metastatic Prostate Cancer. Results from the Local Treatment of Metastatic Prostate C... by Nicolaas Lumen, Elise De Bleser, Sarah Buelens, Wesley Verla, Filip Poelaert, Wietse Claeys, Valérie Fonteyne, Sofie Verbeke, Geert Villeirs, Kathia De Man, Sylvie Rottey, Charles Van Praet, Karel Decaestecker, Piet Ost

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A phase 1 dose escalation study of the oncolytic adenovirus enadenotucirev, administered intravenously to patients with epithelial solid tumors (EVOLVE) by Jean-Pascal Machiels, Ramon Salazar, Sylvie Rottey, Ignacio Duran, Luc Dirix, Karen Geboes, Christine Wilkinson-Blanc, Gillian Pover, Simon Alvis, Brian Champion, Kerry Fisher, Hilary McElwaine-Johnn, John Beadle, Emiliano Calvo

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A phase I/II trial of fixed-dose stereotactic body radiotherapy with sequential or concurrent pembrolizumab in metastatic urothelial carcinoma: evaluation of safety and clinical an... by Nora Sundahl, Katrien De Wolf, Sylvie Rottey, Karel Decaestecker, Daan De Maeseneer, Annabel Meireson, Els Goetghebeur, Valérie Fonteyne, Sofie Verbeke, Pieter De Visschere, Dries Reynders, Mireille Van Gele, Lieve Brochez, Piet Ost

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Immune Monitoring in Melanoma and Urothelial Cancer Patients Treated with Anti-PD-1 Immunotherapy and SBRT Discloses Tumor Specific Immune Signatures by Annabel Meireson, Simon J. Tavernier, Sofie Van Gassen, Nora Sundahl, Annelies Demeyer, Mathieu Spaas, Vibeke Kruse, Liesbeth Ferdinande, Jo Van Dorpe, Benjamin Hennart, Delphine Allorge, Filomeen Haerynck, Karel Decaestecker, Sylvie Rottey, Yvan Saeys, Piet Ost, Lieve Brochez

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Checkpoint inhibition in combination with an immunoboost of external beam radiotherapy in solid tumors (CHEERS): study protocol for a phase 2, open-label, randomized controlled tri... by Mathieu Spaas, Nora Sundahl, Eva Hulstaert, Vibeke Kruse, Sylvie Rottey, Daan De Maeseneer, Veerle Surmont, Annabel Meireson, Lieve Brochez, Dries Reynders, Els Goetghebeur, Robbe Van den Begin, Dirk Van Gestel, Vincent Renard, Piet Dirix, Pieter Mestdagh, Piet Ost

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608 Results of a phase 1 study investigating camidanlumab tesirine as monotherapy and in combination with pembrolizumab in patients with selected advanced solid tumors by Igor Puzanov, Shivaani Kummar, Sylvie Rottey, Patricia LoRusso, Kyriakos P Papadopoulos, Erika Hamilton, Josef Rüschoff, Fiona C Thistlethwaite, Nuria Kotecki, Christopher T Chen, Yvan LeBruchec, Jerzy Dyczkowski, Sara Samari, Marie Toukam, Joseph Boni, Karin Havenith, Serafino Pantano